KRMD — KORU Medical Systems, Inc.

KORU Medical Systems (KRMD) Q4 2025 Earnings Call Summary

1. Key Financial Results and Metrics:

• Q4 Revenue: $10.9 million, representing a 23% year-over-year growth.
• Full Year Revenue: $41.1 million, a 22% increase from $33.6 million in 2024.
• Domestic Core Growth: 18% in Q4, 11% for the full year.
• International Core Growth: 71% in Q4, 80% for the full year.
• Gross Margin: 62.3% for the full year, with a slight reduction due to higher material costs.
• Cash Position: $8.9 million at year-end, with positive cash flow from operations achieved in Q3 and Q4.
• Adjusted EBITDA: Positive $600,000, marking a 124% improvement year-over-year.

2. Strategic Updates and Business Highlights:

• Leadership Transition: CEO Linda Tharby announced her retirement effective June 30, 2026, with Adam Kalbermatten appointed as her successor.
• Regulatory Milestones: Received EU MDR certification for the FREEDOM60 system and 510(k) clearance for RYSTIGGO, expanding the product portfolio.
• Patient Base Growth: Increased recurring patient base to approximately 59,000 global chronic SCIg patients.
• New Collaborations: Announced two new pharmaceutical collaborations, including a Phase III nephrology drug and a Phase I multi-indication drug.
• Market Expansion: Significant growth in international markets, particularly in Europe, with a shift from vial-based delivery to prefilled syringes.

3. Forward Guidance and Outlook:

• 2026 Revenue Guidance: Projected revenue between $47.5 million and $50 million, indicating growth of 15% to 22%.
• Profitability Goals: Targeting positive adjusted EBITDA and cash flow for the full year.
• Market Dynamics: Anticipated growth driven by new drug approvals and continued share gains in both U.S. and international markets.

4. Bad News, Challenges, or Points of Concern:

• PST Business Decline: Experienced a 30% year-over-year decline in the PST business due to timing of contract milestones.
• Geopolitical Risks: Incorporated potential geopolitical risks into revenue guidance, particularly related to recent events in the Middle East.
• Operating Costs: Higher material costs and tariffs impacting gross margins, although still maintaining above 50% margins.

5. Notable Q&A Insights:

• Market Share Gains: Management highlighted the ability to capture market share in the U.S. due to new account gains and the return of a distributor.
• International Growth Potential: Strong expectations for continued growth in international markets, particularly with prefilled syringe conversions.
• Operating Leverage: Management indicated a disciplined approach to operating expenses, with expectations for continued leverage in 2026.
• Oncology Market Entry: The RYSTIGGO approval is seen as a strategic entry point into infusion clinics, which may accelerate future oncology opportunities.

Overall, KORU Medical Systems demonstrated strong financial performance and strategic growth initiatives, while also navigating challenges related to specific business segments and external market conditions. The leadership transition is positioned to maintain momentum moving forward.